Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection

Fresenius Kabi has issued a voluntary nationwide recall of three lots of Famotidine Injection USP, 20 mg per 2 mL (10 mg/mL), after laboratory testing identified an out‑of‑specification impurity result in a single lot. The recall is precautionary and intended to protect patients and maintain supply-chain integrity while further investigations continue.¹

Summary of the recall

• Product recalled: Famotidine Injection USP, 20 mg per 2 mL (10 mg/mL), single‑dose vial.
• Scope: Voluntary nationwide recall of three lots distributed in the United States.¹
• Reason: An out‑of‑specification impurity detected during stability or release testing; additional lots were included as a precautionary measure while the root cause is investigated.¹
• Patient risk: No adverse events tied to the impurity have been publicly reported in the FDA notice; recall is preventative.¹

Regulatory and manufacturer statements

Fresenius Kabi coordinated the recall with the U.S. Food and Drug Administration (FDA). The FDA’s safety communication describes the recall details, identifies the affected product, and confirms that the recall arose from impurity testing results rather than confirmed clinical harm.¹ Fresenius Kabi’s recall communication requests that customers check inventories, quarantine affected lots, and follow the company’s return procedures.

Clinical and safety considerations

Famotidine is an H2‑receptor antagonist commonly used for stress ulcer prophylaxis, gastric acid suppression, and adjunctive therapy in certain gastroesophageal conditions. When a parenteral product undergoes recall for impurity concerns, institutions should:

1. Immediately remove and quarantine the affected lot numbers from clinical areas, automated dispensing cabinets (ADCs), and pharmacies.¹
2. Suspend administration of suspect vials until lot verification and alternative supply are confirmed.
3. Notify treating teams and update electronic medication administration records and order sets to prevent inadvertent selection of quarantined lots.
4. Monitor patients who recently received the product for unexpected adverse effects, document any findings, and report events through institutional safety channels and to the manufacturer and FDA as appropriate.¹

No change to standard monitoring beyond routine post‑infusion observation is recommended unless clinical signs suggest a reaction potentially linked to the product.

Inventory management and substitution

• Triage current on‑hand stock by lot number and expiration date; segregate recalled lots and mark them clearly for return or disposal per manufacturer instructions.¹
• Consider validated therapeutic alternatives for IV acid suppression (e.g., intravenous proton‑pump inhibitors) where clinically appropriate, taking into account indication, renal function, drug interactions, and formulary status.
• Update procurement teams to communicate demand forecasts and preempt shortages; work with wholesalers and the manufacturer for replacement product where available.

Communication and documentation

• Maintain a clear audit trail: record lot numbers, quantities quarantined, patient exposures (if any), and communications with Fresenius Kabi and the FDA.
• Inform frontline clinicians, nursing leadership, and pharmacy staff via email and intranet notices with explicit guidance on identification and handling of recalled lots.
• Share documentation with quality/safety committees and include the recall in periodic medication‑safety reports.

Practical checklist for hospitals and pharmacies

• Verify lot numbers against the FDA notice and manufacturer recall letter; isolate any matches.¹
• Stop dispensing or administering matched lots; secure them in a quarantine area labeled “Recalled—Do Not Use.”
• Follow manufacturer return instructions and regulatory reporting requirements.
• Use clinical judgment for patients recently dosed; escalate any unexpected clinical events to pharmacovigilance.

This voluntary recall is a precautionary action initiated after laboratory detection of an out‑of‑specification impurity in one lot, with two additional lots included while investigations proceed.¹ There is no public evidence of patient harm linked to these lots, but strict inventory control, timely communication, and documentation are essential to maintain patient safety and therapeutic continuity.

Recalled Lots:

Product Name/Size	Unit of Use NDC Number	Unit of Sale NDC Number	Product Code	Batch Number	Expiration  Date	First Ship Date	Last Ship Date
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2mL fill in a 2 mL vial	63323-739-11	63323-739-12	730912	6133156	08/2026	01/02/2025	02/11/2025
				6133194	08/2026	02/04/2025	04/11/2025
				6133388	10/2026	05/23/2025	05/23/2025

Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. Patients should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time, or send an e-mail to either productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@fresenius-kabi.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Reference

1. U.S. Food and Drug Administration. “Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP 20 mg/2 mL (10 mg/mL).” FDA Safety Alerts. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-three-lots-famotidine-injection-usp-20-mg-2-ml-10.